A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.

A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005131-40-ES

Enrollment

176

Registered

2016-09-09

Start date

2016-10-20

Completion date

Unknown

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

"Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 Pharmaceutical Form: Capsule, hard INN or Proposed INN: PIRFENIDONE CAS Number: 53179-13-8 Current Sponsor code: RO0220912 Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 40-80 years (inclusive) at Screening - Diagnosis of IPF for at least 3 months prior to screening - Confirmation of IPF diagnosis by the Investigator, in accordance with the 2011 international consensus guidelines, at Screening - Advanced IPF as defined by a measurable carbon monoxide diffusing capacity/pulmonary diffusing capacity [DLCO] =65 years) yes F.1.3.1 Number of subjects for this age range 132

Exclusion criteria

Exclusion criteria: - History of any of the following types of PH: Group 1 pulmonary arterial hypertension (PAH); Group 2 (left-heart disease); Group 3 (due to conditions other than interstitial lung disease; Group 4 (chronic thromboembolic pulmonary hypertension); Group 5 (other disorders) - History of clinically significant cardiac disease in the opinion of the Investigator - History of coexistent and clinically significant (in the opinion of the Investigator) COPD, bronchiectasis, asthma, inadequately treated sleep-disordered breathing, or any clinically significant pulmonary diseases or disorders other than IPF or PH secondary to IPF - Hypotension, autonomic dysfunction, or conditions in which vasodilation may cause an unsafe drop in blood pressure (BP) - History of use of drugs and toxins known to cause PAH

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of adding sildenafil compared with placebo to pirfenidone treatment in patients with advanced IPF and intermediate or high probability of Group 3 pulmonary hypertension (PH) on the basis of relevant decline in 6-minute walk distance (6MWD) of at least 15% from baseline, respiratory-related non-elective hospitalizations, or all-cause mortality;Secondary Objective: •To evaluate the efficacy of adding sildenafil compared with placebo to pirfenidone treatment on the basis of Progression-free survival (PFS) Proportion of patients with decline in 6MWD of >=15% from baseline Time to all-cause and respiratory-related non-elective hospitalization Time to death from any cause and respiratory-related death Lung transplantation Change from baseline in transthoracic echocardiography (ECHO) parameters, pulmonary function tests (PFTs), and oxyhemoglobin saturation (SpO2) at rest and during the 6MWT World Health Organization (WHO) Functional Class Dyspnoea (assessed by the University of California San Diego Shortness of Breath questionnaire [UCSD SOBQ]) Health-related quality of life (HRQoL) (assessed by the Saint George’s Respiratory Questionnaire [SGRQ]) N-terminal pro-brain natriuretic peptide (NT-proBNP) level (assessed by a blood test);Primary end point(s): The primary efficacy endpoint will be evaluated based on a comparison of the proportion of patients showing disease progression over 52 weeks of treatment period, as evidenced by reaching the following combined endpoint: •Relative decline in 6MWD of at least 15% from baseline (as defined in the protocol), respiratory related non elective hospitalization, or all cause mortality;Timepoint(s) of evaluation of this end point: •The primary analysis of the study will be conducted when all patients completed the 52 weeks treatment phase and the mandatory 4 weeks follow-up visit.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of adding sildenafil compared with placebo to pirfenidone treatment in patients with advanced IPF and intermediate or high probability of Group 3 pulmonary hypertension (PH) on the basis of relevant decline in 6-minute walk distance (6MWD) of at least 15% from baseline, respiratory-related non-elective hospitalizations, or all-cause mortality;Secondary Objective: •To evaluate the efficacy of adding sildenafil compared with placebo to pirfenidone treatment on the basis of Progression-free survival (PFS) Proportion of patients with decline in 6MWD of >=15% from baseline Time to all-cause and respiratory-related non-elective hospitalization Time to death from any cause and respiratory-related death Lung transplantation Change from baseline in transthoracic echocardiography (ECHO) parameters, pulmonary function tests (PFTs), and oxyhemoglobin saturation (SpO2) at rest and during the 6MWT World Health Organization (WHO) Functional Class Dyspnoea (assessed by the University of California San Diego Shortness of Breath questionnaire [UCSD SOBQ]) Health-related quality of life (HRQoL) (assessed by the Saint George’s Respiratory Questionnaire [SGRQ]) N-terminal pro-brain natriuretic peptide (NT-proBNP) level (assessed by a blood test);Primary end point(s): The primary efficacy endpoint will be evaluated based on a comparison of the proportion of patients showing disease progression over 52 weeks of treatment period, as evidenced by reaching the following combined endpoint: •Relative decline in 6MWD of at least 15% from baseline (as defined in the protocol), respiratory related non elective hospitalization, or all cause mortality;Timepoint(s) of evaluation of this end point: •The primary analysis of the study will be conducted when all patients completed the 52 weeks treatment phase and the mandatory 4 weeks follow-up visit.

—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy: 1.Progression-free survival (PFS) 2.Proportion of patients with decline in 6MWD of >=15% from baseline 3.Time to respiratory-related non-elective hospitalization 4.Time to death from any cause 5.Lung transplantation will be analysed descriptively 6.Time to all-cause non-elective hospitalization 7.Time to respiratory-related death 8.Change from baseline in transthoracic ECHO parameters 9.Change from baseline in PFTs (FVC, FEV1, FEV1/FVC, and DLCO) 10.Oxyhemoglobin saturation (SpO2) at rest and during the 6MWT will be summarized descriptively over time 11.Borg scale measurement of perceived exertion will be summarized descriptively over time 12.WHO Functional Class II or III over time 13.Dyspnea as assessed by UCSD SOBQ will be summarized descriptively over time 14.HRQoL (assessed by SGRQ) will be summarized descriptively over time 15.Changes from baseline in NT-proBNP levels Safety: 16.Nature, frequency, severity, relationship and timing of treatment-emergent adverse events 17.Changes in vital signs, physical examination, clinical laboratory test results, 12-lead electrocardiograms (ECGs) 18.Proportion of patients with study discontinuation or study drug discontinuation;Timepoint(s) of evaluation of this end point: 1-18. The primary analysis of the study will be conducted when all patients completed the 52 weeks treatment phase and the mandatory 4 weeks follow-up visit.	—

Measure

Time frame

Secondary end point(s): Efficacy: 1.Progression-free survival (PFS) 2.Proportion of patients with decline in 6MWD of >=15% from baseline 3.Time to respiratory-related non-elective hospitalization 4.Time to death from any cause 5.Lung transplantation will be analysed descriptively 6.Time to all-cause non-elective hospitalization 7.Time to respiratory-related death 8.Change from baseline in transthoracic ECHO parameters 9.Change from baseline in PFTs (FVC, FEV1, FEV1/FVC, and DLCO) 10.Oxyhemoglobin saturation (SpO2) at rest and during the 6MWT will be summarized descriptively over time 11.Borg scale measurement of perceived exertion will be summarized descriptively over time 12.WHO Functional Class II or III over time 13.Dyspnea as assessed by UCSD SOBQ will be summarized descriptively over time 14.HRQoL (assessed by SGRQ) will be summarized descriptively over time 15.Changes from baseline in NT-proBNP levels Safety: 16.Nature, frequency, severity, relationship and timing of treatment-emergent adverse events 17.Changes in vital signs, physical examination, clinical laboratory test results, 12-lead electrocardiograms (ECGs) 18.Proportion of patients with study discontinuation or study drug discontinuation;Timepoint(s) of evaluation of this end point: 1-18. The primary analysis of the study will be conducted when all patients completed the 52 weeks treatment phase and the mandatory 4 weeks follow-up visit.

—

Countries

Belgium, Canada, Czech Republic, Egypt, Germany, Greece, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Turkey, United Arab Emirates

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com34913257300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026